Citalopram hydrobromide (Celexa - Forest/Parke-Davis), a selective serotonin reuptake inhibitor (SSRI) available in Europe since 1989, has now been approved by the US Food and Drug Administration (FDA) for treatment of depression. It is being advertised as having a 'favorable side-effect profile.'

Quinupristin and dalfopristin, two streptogramin antibacterials marketed in a 30:70 combination as Synercid, have received accelerated approval from the FDA for intravenous treatment of bacteremia and life-threatening infection....

The FDA has approved belatacept (bel at´ a sept; Nulojix – Bristol-Myers Squibb) for prevention of organ rejection in adult patients receiving a kidney transplant.

Sildenafil (Viagra), tadalafil (Cialis) and vardenafil (Levitra, Staxyn) have become the standard treatment for erectile dysfunction. Head-to-head comparisons of these agents are still lacking, but some differences between them and new recommendations for their dosing (see Table 2) are worth noting.

Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. It is the fourth oral tyrosine kinase inhibitor to be approved for treatment of advanced renal cell carcinoma.

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...

Apremilast (Otezla – Celgene), an oral phosphodiesterase type-4 (PDE4) inhibitor, has been approved by the FDA for treatment of active psoriatic arthritis in adults. It is the fi rst PDE4 inhibitor to be approved for this indication.

The FDA has approved belinostat (Beleodaq – Spectrum), an IV histone deacetylase (HDAC) inhibitor, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the third IV drug approved by the FDA for PTCL. The first was the antifolate drug pralatrexate (Folotyn), which was followed by the HDAC inhibitor romidepsin (Istodax). Vorinostat (Zolinza), an oral HDAC inhibitor, is FDA-approved for treatment of cutaneous T-cell lymphoma.

The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Pemigatinib is the first drug to be approved in the US for this indication.